FDA Device recall Z-2084-2019
RX Imola, Model Nos
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of RX Imola, Model Nos by Randox Laboratories, citing there was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2084-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-24 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Randox Laboratories |
| Distribution | CA, CT, MA, MD, MO, NC, NJ, NY, OH, PA, PR, UT, WV |
Product
RX Imola, Model Nos. RX4900
Reason
There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2084-2019%22
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